- higher education (technological, chemical, biotechnological)
- knowledge of the medicines production and knowledge of requirements for the development of medicines
- knowledge of GMP standards
- personal qualities: well-organized, responsible, active, has developed communication skills, able to learn quickly
- confident PC user (MS Office, Internet)
- knowledge of English at a level not lower than Intermediate
- development of the composition and technology of production of finished drugs (aseptic medicines)
- participation in projects for development and implementation of new medicines (production of laboratory, research and industrial, first industrial series)
- development of regulatory documentation (technological regulations) in accordance with GMP requirements
- preparation of Module 3 materials of the Registration Dossier in CTD format
- higher education in Chemistry or Pharmacy
- knowledge of the basics of analytical chemistry
- experience in a chemical laboratory, readiness to study
- pharmaceutical development and validation of analytical methods of analysis,
- development of new test methods and devices,
- evaluation of analysis results,
- quality control of reference substances, experimental series,
- tests of stability of new medicines,
- registration of documentation.
Validation department quality specialist
- higher technical, technological, chemical or pharmaceutical education;
- knowledge of Microsoft Word, Excel, Visio programs;
- ability to work with control and measuring devices;
- ability to think critically and analyze;
- willingness to study.
- basic knowledge of the principles of statistical data processing;
- understanding of the basic principles of technological equipment;
- proficiency in English at the level of reading / translating technical documentation;
- residence in Novohrad-Volynskyi or district.
- development of validation documentation (protocols, schedules, schemes);
- conducting qualification tests of equipment, technical systems;
- conducting validation tests of technological processes;
- filling in forms based on test results;
- analysis and processing of the received data, formation of reports.
- official employment;
- full social package;
- opportunity for training and professional growth.
The amount of salary shall be determined by results of the interview, meets the market level.